Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of ribavirin in healthy adult subjects under fed condition

Conditions: Healthy Subjects

Summary: to evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing ribavirin 400 mg, after administering a single oral dose, to healthy adult subjects under fed conditions.

enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (t) or the reference product (r) each phase, under fed conditions, with a wash-out period of 42 days. ribavirin plasma concentration was determined using a validated lc-ms-ms method, followed by pharmacokinetics, and statistical analysis using phoenix winnonlin® software to determine the average bioequivalence.

Eligibility criteria:
inclusion criteria: * written informed consent is obtained for the study * age 18 - 55 years * body mass index between 18.5 and 30 kg/m2 * have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination. * vital signs without significant deviations. * all laboratory screening results are within the normal range or clinically non-significant exclusion criteria: * history or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator. * history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer. * any confirmed significant allergic reactions against any drug or multiple allergies. * clinically significant illness 28 days before study phase i. * alcohol or any solvent intake. * regular use of medication. * positive urine screening of drugs of abuse. * use of any systemic medications (prescription medications, otc products, supplements, or herbal preparations) for 14 days prior to dosing and during the study. * history or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout. * blood donation within the past 60 days. * participation in another bioequivalence study within 60 days prior to the start of phase i of the study.

Keywords: bioequivalence randomized crossover ribavirin
intraoperative assessment of ureteral perfusion in women with endometriosis

Conditions: Endometriosis

Summary: deep infiltrating endometriosis (die) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. it is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. it is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters. indocyanine green (icg) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (nir). nir-icg imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.

patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study. ureter perfusion will be intraoperatively assessed using indocyanine green angiography. after surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic surgery for endometriosis * informed consent to participate in the study exclusion criteria: * known or suspected allergy to iodide * history of active pelvic infection * presence of intra-abdominal or pelvic malignancy * pelvic radiation therapy * hyperthyroidism * liver dysfunction * serum creatinine \> 2.0 mg/dl

Keywords: endometriosis ureters indocyanine green angiography
comparing efficacy and complication between prone versus prone-flexed position for percutaneous nephrolithotomy (pcnl)

Conditions: Urolithiasis; Kidney Stone; Complication

Summary: comparing efficacy and complication between prone versus prone-flexed position for percutaneous nephrolithotomy (pcnl)


Eligibility criteria:
inclusion criteria: 1. staghorn calculi 2. renal pelvis stones \&gt;2 cm 3. lower pole stones \&gt;1.5 cm 4. swl-resistant stones exclusion criteria: 1. age \&lt;18 years or pregnancy 2. bilateral simultaneous pcnl 3. need for 3 percutaneous tracts intraoperative 4. morbid obesity (bmi \&gt;40) 5. non opaque renal stones. 6. refuse to complete study requirements 7. atypical bowel interposition need ct guided puncture 8. tumour in the presumptive access tract area or potential malignant kidney tumour
oxygen supplementation during bronchoscopy: high flow versus low flow oxygen

Conditions: Hypoxia

Summary: in general bronchoscopy is a safe procedure with low rate of complications. indeed, contraindications to flexible bronchoscopy are mostly relative rather than absolute. this is the case of preexisting decreased blood oxygen levels which may be present in patients requiring further bronchopulmonary investigation. to avoid the deleterious effects of oxygen drops oxygen supplementation is recommended. the purpose of this study is to evaluate the efficiency and safety of oxygen supplementation obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula during flexible bronchoscopy. consecutive patients referred by their treating physician for bronchoscopy will be offered to take part in the study. those who wish to participate and give their consent will be randomly assigned into one of two treatment groups (supplemental oxygen given via low flow nasal cannula or via high flow nasal cannula). assignment to either treatment arm will not affect in any way the intended purpose of the bronchoscopy. all patients will be closely monitored during the procedure and 2 hours following its completion. monitoring will be conducted, using strictly non-invasive measures.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo routine bronchoscopy for diagnostic purposes exclusion criteria: * inability to give an informed consent * nasal deformities

Keywords: bronchoscopy hypoxia oxygen supplementation safety
assessing risk of food insecurity within households of children with food allergy

Conditions: Food Allergy; Asthma; Allergic Rhinitis; Atopic Dermatitis; Eosinophilic Esophagitis

Summary: our central hypothesis is that dietary limitations introduced by food allergy will contribute to increased food insecurity in households with food allergic children when compared to food insecure households without food allergic children.

specific aim 1 to describe food insecurity in families of the pediatric allergy population, specifically comparing the prevalence of food insecurity rates between households of food allergic patients and households of allergic patients without food allergy. specific aim 2 to examine health literacy in parents of patients in the pediatric allergy population, comparing food insecure patients with and without food allergy to food secure patients with food allergy. specific aim 3 to examine quality of life in food allergic patients' households using the food allergy impact scale, comparing food allergic patients' households with food insecurity to food allergic patients' households without food insecurity.

Eligibility criteria:
inclusion criteria: * parents whose child has an allergy appointment with the allergy and immunology department at arkansas children's hospital between 1-17 years of age with allergic disease exclusion criteria: * parents whose child has an allergy appointment with the allergy and immunology department at arkansas children's hospital less than 1 years of age or 18 years of age and older will not be eligible to participate in this study. children with immunodeficiency disease will be excluded.

Keywords: food insecurity health literacy quality of life
spp100 (aliskiren) regimen in patients with severe hypertension

Conditions: Hypertension

Summary: assessing the safety and efficacy of spp100 (aliskiren) regimen in patients with severe hypertension


Eligibility criteria:
inclusion criteria: * age: 20 - 80 years old * gender: male or female * status: outpatients * severe hypertension exclusion criteria: * patients with a clinically significant allergy * patients who have received other investigational drug * alcoholic patients other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, aliskiren, blood pressure, rennin
investigation of transcutaneous auricular vagus nerve stimulation efficacy in female fibromyalgia patients

Conditions: Fibromyalgia Syndrome

Summary: this study aimed to examine the effects of transcutaneous auricular vagus nerve stimulation (tavns) on pain, depression, anxiety, functionality, and autonomic function in fibromyalgia syndrome (fms). primary hypothesis: tavss application is not an effective treatment for depression, physical limitation, functional disability, anxiety, pain and autonomic nerve system in female fms patients. secondary hypothesis: tavss application is an effective treatment for depression, physical limitation, functional disability, anxiety, pain and autonomic nerve system in female fms patients.


Eligibility criteria:
inclusion criteria: * female volunteer participants * aged 18-45 with regular menstrual cycles * diagnosed with fms (widespread pain index≥ 17 * symptom severity scale≥ 21) according to the 2013 acr diagnostic criteria by a specialist physician. exclusion criteria: * neurological deficits, * diabetes * neuropathic disorders * chronic inflammation * immune deficiencies * cardiac diseases * pregnancy * being in the perimenopausal or postmenopausal stages, * menstrual cycles of less than 28 days, * started new medication within the last 3 months, * modifications to their existing treatment apart from tavns.
effect of platelet rich plasma (prp) on the esthetic outcome and scar formation of unilateral cleft lip repair

Conditions: Unilateral Cleft Lip

Summary: the purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair.

prp is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values. prp is made by centrifugation of whole blood (drawn from a peripheral vein and stored in an acid citrate dextrose solution a (acd-a) anticoagulant), which separates the various components of blood by their specific weight and increases the concentration of platelets. platelets are a rich source of the complex group of proteins called growth factors (gfs) involved in natural wound healing and in regeneration of injured tissues. gfs are active signals for attracting stem cells into the site of injury and triggering proliferation of these cells. prp limit inflammation, interacting with macrophages to improve tissue healing and regeneration, promote new capillary growth, and accelerate epithelialization. platelets in prp also play a role in host defense mechanism at the wound site by producing signaling proteins that attract macrophages; prp also may contain a small number of leukocytes that synthesize interleukins as part of a non-specific immune response. previous studies of prp have demonstrated antimicrobial activity against escherichia coli, staphylococcus aureus, including methicillin-resistant staphylococcus aureus, candida albicans, and cryptococcus neoforma. so, prp is effective in soft tissue healing, having no side effect and showed excellent healing score in skin wound healing.

Eligibility criteria:
inclusion criteria: * patients with nonsyndromic cleft lip * primary, unilateral, complete or incomplete cleft lip * patient's age younger than six months * lip repair performed by one craniofacial surgeon * completeness of medical records including preoperative and postoperative photographs at approximately 6 months after surgery exclusion criteria: * patients with syndromic cleft lip * secondary lip treatment (previous operated cases) * bilateral cleft lip * patient older than six months * associated cardiac anomalies * any systemic condition

Keywords: cleft lip repair cheiloplasty prp platelet rich plasma
femtosecond laser assisted cataract surgery in intumescent cataracts

Conditions: Intumescent Cataract

Summary: the purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. an intumescent cataract is defined as a cataract with a pressurized capsular bag.


Eligibility criteria:
inclusion criteria: * willing to undergo cataract surgery. * able to lie flat in a supine position. * able to understand and willing to sign the informed consent form (icf). * presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex. * other protocol-specified inclusion criteria may apply. exclusion criteria: * pregnant or lactating mothers. * corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength. * corneal opacity that would interfere with the laser beam. * presence of blood or other material in the anterior chamber. * hypotony or presence of corneal implant. * poorly dilating pupils. * condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium. * residual, recurrent, active ocular or eye lid disease, including any corneal abnormality. * any contraindication to cataract surgery. * other protocol-specified exclusion criteria may apply.
effect of pilates training in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: knee flexor and extensor muscle weakness in ms patients causes a decrease in walking distance and is an important determinant of walking capacity. exercise training has beneficial effects on muscle strength, balance, and walking in ms patients. although the effects of aerobic and resistant exercise training in ms patients are often emphasized, today the effect of different exercise types is also wondered. pilates is a core stability-based exercise method that improves endurance, flexibility, movement, posture, and respiratory control. the aim of this study is to examine the effect of pilates training on sensation, muscle strength, balance, and walking in ms patients.

patients with ms between 0-5,5 score according to the extended disability status scale (edss) will be included in the study. the balance, gait, position sense, and muscle strength will be evaluated. the study was designed as a prospective, randomized controlled study. the patients will be randomly assigned to two groups, the "pilates training" group, and the control group. pilates training will be performed by the pilates training group 2 times for 8 weeks under supervision in the outpatient clinic. the control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 8 weeks at home. statistical analyses will be performed using the spss software version 15 (spss inc. chicago, il, usa). the pre-training and post-training measurements of groups will be compared with the paired sample t-test.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * having a diagnosis of "multiple sclerosis" * relapse free in the last 3 mounts * having an ambulatory status (expanded disability status scale score ≤ 6 ) * no diagnosis of depression exclusion criteria: * any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research.

Keywords: multiple sclerosis sensation gait pilates
korea post marketing surveillance (pms) study of vizimpro

Conditions: Lung Neoplasms

Summary: vizimpro will be approved for the treatment of egfr nslcl 1l in korea. in accordance with the standards for re-examination of new drug, it is required to conduct a pms. post marketing surveillance is required to determine any problems or questions associated with vizimpro after marketing in korea, with regard to the following clauses under conditions of general clinical practice. therefore, through this study, effectiveness and safety of vizimpro will be observed.


Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. vizimpro® naïve patients to whom vizimpro® can be prescribed as per the local labeling (the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 19 deletion or exon 21 l858r substitution mutations 2. evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study exclusion criteria patients meeting any of the following criteria will not be included in the study: 1. patients to whom vizimpro® is contraindicated as per the local labeling. a. hypersensitivity to the active substance or to any of the excipients of this product. b. this medicinal product contains lactose. patients with rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. 2. any patients (or a legally acceptable representative) who does not agree that pfizer and companies working with pfizer use his/her information.

Keywords: egfr nsclc
low level laser therapy for hair preservation with chemotherapy for breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to see whether low level laser therapy can help maintain normal hair growth on the scalp in people receiving chemotherapy, which is generally associated with hair loss.

chemotherapy is a common treatment given to patients with breast cancer. many chemotherapy drugs cause rapid hair loss. while hair loss is temporary, this side effect is a significant concern for patients. low level laser therapy has been shown to help make hair grow. it is hoped that it may stop hair loss from occurring. participants will be receiving 20 to 30 minute laser sessions to their scalp twice a week beginning two weeks before treatment begins until one week past the last chemotherapy session. . photographs will be taken during each study participant's initial visit, during treatment visits, and one month following the final chemotherapy treatment.

Eligibility criteria:
inclusion criteria: * participants must have breast cancer and must be starting chemotherapy with adriamycin or a taxane-based therapy. * participants must be 18 years old or older * participants must be female * participant must agree to comply with therapeutic and follow-up schedule. * patient must signed informed consent form. exclusion criteria: * participants cannot have sensitivity to the laser light. * participants cannot have used any topical or oral products to grow hair within 3 months of enrollment to this study. * participants cannot be pregnant, lactating or planning on pregnancy during therapeutic schedule.

Keywords: breast cancer
neurofibromatosis type 1 patient registry

Conditions: Neurofibromatosis Type 1

Summary: the neurofibromatosis type 1 (nf1) patient registry initiative (npri) is a web-based registry that asks participants to fill out a 30-minute online questionnaire to collect information about the spectrum of medical and social problems experienced by children and adults with nf1. the information gained from your participation may one day help doctors develop personalized treatments for individuals living with nf1. we are currently enrolling individuals with nf1 who either (1) have previously been diagnosed with a brain tumor younger than 18 years or (2) have never had a brain tumor. please note: there is no therapy associated with this study. individuals may participate in the registry by going to https://nf1registry.wustl.edu/


Eligibility criteria:
inclusion criteria: * individuals diagnosed by a healthcare provider with neurofibromatosis type 1 exclusion criteria: * individuals without a healthcare provider diagnosis of neurofibromatosis type 1

Keywords: nf1 neurofibromatosis nf
transdermal continuous oxygen therapy for infection prophylaxis in high- risk patients undergoing colon surgery

Conditions: Anorectal Surgeries

Summary: epiflo® unit along with standard wound care vs only standard wound care for surgical site infections (ssi).

anorectal procedures more often lead to surgical site infections. such infections are unfortunately frequent and can be difficult for the patient and the treating physician. wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. transdermal oxygen delivery (epiflo) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment

Eligibility criteria:
inclusion criteria: * elective colo-rectal surgery with or without anastomosis and with or without stoma * patient age: 18-80 exclusion criteria: * pregnancy * anesthesiology asa score of 4 or above * fever or existing signs of infection at the time of surgery * diabetes mellitus type i or ii with hba1c level 12% or more * persons with decubitus or diabetic ulcers * subjects with peritoneal metastases * patients with severe malnutrition as indicated by prealbumin value of \<20 * bmi ≥50

Keywords: anorectal surgeries infection topical oxygen
clinical study to evaluate the impact of akwa skincare system on skin health

Conditions: Sin Health; Skin Hydration; Skin Wrinkles; Skin Porphyrins; Facial Skin Red Spots; Facial Skin Red Vasculature

Summary: the purpose of the study was to evaluate the effectiveness of the äkwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.

the äkwä 6-step skincare system is comprised of various skincare products intended to be applied both morning and night. some of the notable ingredients included in the product formulas are fermented green tea water, other ferments, niacinamide, antioxidants, and a variety of natural plant extracts. the purpose of the study was to evaluate the effectiveness of the äkwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.

Eligibility criteria:
inclusion criteria: * individuals could participate who were at least 18 years old and in good health. exclusion criteria: * had allergies or contraindications to any ingredient of products, * had a history of any acute or chronic disease that could interfere with or increase the risk of study participation * had any medical procedures, such as laser resurfacing, or plastic surgery to the test sites within the last 12 months (including botox, restylyn, or other fillers) * chronic skin allergies (dermatitis, eczema, psoriasis) * had been treated for skin cancer within the last 12 months or have damaged skin near the facial area (e.g., sunburn, tattoos, scars, or other disfigurations) * pregnant or planning to become pregnant in the following 12 weeks, or lactating